Comparison of Different Analgesia Drug Regimens for Pain Control During ESWL for Renal Stones

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-01-31

Brief Summary

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We want to compare the effect of lignocaine 2 % gel, Naproxen sodium and their combination on the pain control during extracorporial shock wave lithotripsy for renal stones.

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Detailed Description

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Introduction of ESWL (extracorporeal shock wave lithotripsy) has revolutionized the treatment of urolithiasis due to its noninvasive in nature, cost effectiveness, reduced hospitalization time and less morbidity1, 2.Impact of shock waves cause pain in most of the patient requiring analgesia or sedation. It is important to make patient pain free to get the maximum possible stone free rates3, 4. Opioids are used most commonly for pain relief in ESWL but with side effects requiring patient monitoring and delayed hospital stay3, 4. NSAIDS also showed promising results regarding pain control in ESWL without side effects of opoids1, 5. Local analgesia gels have controversial role in relieving pain in ESWL 1, 6. There are yet no guidelines for pain relief during ESWL1, 4. We intend to compare the effect of local analgesia gel, oral NSAIDS and their combination on pain during lithotripsy.

Conditions

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Renal Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Lidocaine gel

20 grams Lidocaine gel 2 % will be applied to corresponding lumber area of the patients 30 minutes before undergoing ESWL for renal stone.Max 4000 shockwaves will be administered. Rescue intravenous nalbuphine will be administered during procedure.Visual analogue pain score will be measured after completion of procedure or during procedure just before giving rescue iv analgesia if needed.

Group Type ACTIVE_COMPARATOR

Lidocaine gel,

Intervention Type DRUG

2% lidocain gel will be applied to coresponding lumber area 30 minutes before ESWL for renal stones. Maximum of 4000 shock waves will be delivered. Rescue analgesia will be given as intravenous nalbuphine if patient demanded. Pain score is measured with visual analogue pain score from 1 to 10 after completion of procedure if patient donot needed rescue analgesia and during procedure just before giving rescue analgesia in those who demanded it.

Naproxen Sodium

Oral Naproxen sodium 550 mg will given to patients 45 minutes before ESWL for renal stones.Max 4000 shockwaves will be administered. Rescue intravenous nalbuphine will be administered during procedure.Visual analogue pain score will be measured after completion of procedure or during procedure just before giving rescue iv analgesia if needed.

Group Type ACTIVE_COMPARATOR

Naproxen Sodium

Intervention Type DRUG

Tab Naproxen sadium 550 mg per oral will be given to patients 30 minutes before ESWL for renal stones. Maximum of 4000 shock waves will be delivered. Rescue analgesia will be given as intravenous nalbuphine if patient demanded. Pain score is measured with visual analogue pain score from 1 to 10 after completion of procedure if patient donot needed rescue analgesia and during procedure just before giving rescue analgesia in those who demanded it.

Lidocaine Gel and Naproxen Sodium

Oral Naproxen sodium 55o mg and locally applied 2 % lidocaine gel to patients before ESWL for renal stones.Max 4000 shockwaves will be administered. Rescue intravenous nalbuphine will be administered during procedure.Visual analogue pain score will be measured after completion of procedure or during procedure just before giving rescue iv analgesia if needed.

Group Type ACTIVE_COMPARATOR

Lidocaine gel and Naproxen Sodium

Intervention Type DRUG

Tab Naproxen sodium 550 mg per oral will be given to patients 45 minutes before ESWL and 2% lidocain gel will be applied to coresponding lumber area 30 minutes before ESWL for renal stones. Maximum of 4000 shock waves will be delivered. Rescue analgesia will be given as intravenous nalbuphine if patient demanded. Pain score is measured with visual analogue pain score from 1 to 10 after completion of procedure if patient donot needed rescue analgesia and during procedure just before giving rescue analgesia in those who demanded it.

Interventions

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Lidocaine gel,

2% lidocain gel will be applied to coresponding lumber area 30 minutes before ESWL for renal stones. Maximum of 4000 shock waves will be delivered. Rescue analgesia will be given as intravenous nalbuphine if patient demanded. Pain score is measured with visual analogue pain score from 1 to 10 after completion of procedure if patient donot needed rescue analgesia and during procedure just before giving rescue analgesia in those who demanded it.

Intervention Type DRUG

Naproxen Sodium

Tab Naproxen sadium 550 mg per oral will be given to patients 30 minutes before ESWL for renal stones. Maximum of 4000 shock waves will be delivered. Rescue analgesia will be given as intravenous nalbuphine if patient demanded. Pain score is measured with visual analogue pain score from 1 to 10 after completion of procedure if patient donot needed rescue analgesia and during procedure just before giving rescue analgesia in those who demanded it.

Intervention Type DRUG

Lidocaine gel and Naproxen Sodium

Tab Naproxen sodium 550 mg per oral will be given to patients 45 minutes before ESWL and 2% lidocain gel will be applied to coresponding lumber area 30 minutes before ESWL for renal stones. Maximum of 4000 shock waves will be delivered. Rescue analgesia will be given as intravenous nalbuphine if patient demanded. Pain score is measured with visual analogue pain score from 1 to 10 after completion of procedure if patient donot needed rescue analgesia and during procedure just before giving rescue analgesia in those who demanded it.

Intervention Type DRUG

Other Intervention Names

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Lignicaine NSAIDS NSAIDS and Lidocaine

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 70 years Having renal stone Meet the criteria for ESWL

Exclusion Criteria

* H/o chronic use of analgesia, 2) Allergy to any of the used medications, 3) those having ureteric stones, 4) Serum creatinine\>1.4, 5) Pregnant patients, 6) having gastric ulcer disease, 7) not willing to participate, 8) Have coagulopathy and 9) active urinary-tract infection.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes